Table 1.
Model development | External evaluation | |||||||
---|---|---|---|---|---|---|---|---|
Number | Mean | Median | 95% observation interval | Number | Mean | Median | 95% observation interval | |
Patients (Oslo / Brisbane) | 69 / 173 | 72 / 0 | ||||||
Sex (Male / Female) | 165 / 77 | 50 / 22 | ||||||
CYP3A5 genotype (*1/*1, *1/*3, *3/*3)* | 3 / 33 / 205 | 0 / 14 / 58 | ||||||
Age (years) | 48 | 48 | 23–71 | 53 | 56 | 26–74 | ||
Height (cm) | 173 | 175 | 152–193 | 175 | 175 | 159–192 | ||
Total body weight (kg) | 82 | 80 | 51–121 | 77 | 77 | 50–99 | ||
Predicted fat free mass (kg) | 57 | 59 | 35–80 | 56 | 59 | 35–71 | ||
Haematocrit (%)† | 33 | 33 | 25–43 | 33 | 33 | 27–43 | ||
Serum albumin (g l−1)† | 36 | 36 | 24–45 | – | – | – | ||
Total serum bilirubin (μmol l−1)† | 11 | 10 | 4–21 | – | – | – | ||
Aspartate aminotransferase (IU l−1)† | 23 | 20 | 9–53 | – | – | – | ||
Alanine aminostransferase (IU l−1)† | 33 | 26 | 11–91 | – | – | – | ||
Alkaline phosphatase (IU l−1)† | 72 | 64 | 35–149 | – | – | – | ||
Prednisolone dose (mg day−1) | 21 | 20 | 5–36 | 20 | 20 | 15–31 | ||
Sampling time (days post-transplant)† | 267 | 20 | 5–2591 | 11 | 11 | 9–13 | ||
Total tacrolimus samples (Oslo / Brisbane) | 3100 (1546 / 1554) | 837 (837 / 0) | ||||||
Tacrolimus samples per patient (Oslo / Brisbane) | 13 (22 / 8) | 8 (24 / 8) | 4–40 (8–40 / 4–16) | 12 | 12 | 9–15 | ||
Tacrolimus dose (mg twice daily)† (Oslo / Brisbane) | 5.8 (3.0 / 6.9) | 6.0 (3.0 / 7.0) | 1.0–10.0 (1.0–6.0 / 1.5–10.0) | 3.0 | 3.0 | 1.8–5.0 | ||
Tacrolimus concentration (μg l−1)‡ (Oslo / Brisbane) | 11.0 (7.0 / 15.0) | 8.4 (6.1 / 13.1) | 2.9–31.0 (2.5–16.6 / 4.2–35.9) | 5.3 | 4.9 | 2.2–10.2 |
Brisbane, Brisbane dataset; CYP3A5, cytochrome P450 3A5; Oslo, Oslo dataset.
Frequency of CYP3A5 genotype was in Hardy–Weinberg equilibrium (Table S1). CYP3A5 genotype was established for all patients except one who was assigned to the most frequent genotype.
Calculated from average within each patient.
Concentrations converted to liquid chromatography-tandem mass spectrometry equivalents if measured with immunoassay, see main text.